Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-08 @ 7:35 AM
Study NCT ID:
NCT02925832
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
Sponsor:
Government Medical College, Haldwani
Organization:
Study Overview
Official Title:
Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTFNB
Brief Summary:
Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. In this study the investigators intend to compare ropivacaine and bupivacaine in various parameters during phacoemulsification.
Detailed Description:
Prospective, study will be conducted on 100 patients undergoing elective cataract surgery by phacoemulsification under Deep topical fornix nerve block at Government medical college, Haldwani, India.
Written informed consent to participate in the study will be taken from all the patients.
Patients will be randomly allocated into two groups, Groups B (Bupivacaine: n=50) and Group R (Ropivacaine: n =50).
Deep topical fornix nerve block (DTFNB) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. The sponges are to be removed after 15-20 minutes. The anesthetic effect will be tested by grasping the limbus with Castroviejo 0.12 tissue forceps. No sedative systemic medications will be given to patients perioperatively.
All surgeries will be performed by the same surgeon. Both patients and surgeon will be blind to which anesthetic agent would be used. A 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. The nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. Foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports.
A simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain). Assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel Incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration.
In case the score being 0 or 1 no intervention will be done. But in cases of score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.
Written informed consent to participate in the study will be taken from all the patients.
Patients will be randomly allocated into two groups, Groups B (Bupivacaine: n=50) and Group R (Ropivacaine: n =50).
Deep topical fornix nerve block (DTFNB) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. The sponges are to be removed after 15-20 minutes. The anesthetic effect will be tested by grasping the limbus with Castroviejo 0.12 tissue forceps. No sedative systemic medications will be given to patients perioperatively.
All surgeries will be performed by the same surgeon. Both patients and surgeon will be blind to which anesthetic agent would be used. A 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. The nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. Foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports.
A simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain). Assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel Incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration.
In case the score being 0 or 1 no intervention will be done. But in cases of score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: